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Effect of Orally Administered Bovine Lactoferrin on the Growth of Adenomatous Colorectal Polyps in a Randomized, Placebo-Controlled Clinical Trial

Authors' Affiliations: ¹ Cancer Screening Division, National Cancer Center, Research Center for Cancer Prevention and Screening; ² Diagnostic Radiology, ³ Endoscopy, and ⁴ Colorectal Surgery, National Cancer Center Hospital; ⁵ Department of Biostatistics, School of Health Sciences and Nursing, The University of Tokyo; ⁶ National Cancer Center, Tokyo, Japan; and ⁷ Department of Molecular Toxicology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

Requests for reprints: Hiroyuki Tsuda, Department of Molecular Toxicology, Nagoya City University Graduate School of Medical Sciences, 1-Kawasumi, Mizuho-ku, Mizuho-cho, Nagoya 467-8601, Japan. Phone: 81-52-853-8991; Fax: 81-52-853-8996; E-mail: htsuda{at}med.nagoya-cu.ac.jp.

Lactoferrin (LF), a secreted, iron binding glycoprotein originally discovered as a component of milk, is found in a variety of exocrine secretions and in the secondary granules of polymorphonuclear leukocytes. Animal experiments have shown that oral administration of bovine lactoferrin (bLF) exerts anticarcinogenesis effects in the colon and other organs of the rat. The aim of this study was to determine whether oral bLF could inhibit the growth of adenomatous colorectal polyps in human patients. A randomized, double-blind, controlled trial was conducted in 104 participants, ages 40 to 75 years, with polyps 5 mm in diameter and likely to be adenomas. Participants were assigned to receive placebo, 1.5-g bLF, or 3.0-g bLF daily for 12 months. Target adenomatous polyps were monitored by colonoscopy. Ingestion of 3.0-g bLF significantly retarded adenomatous polyp growth in participants 63 years old or younger. Removal of adenomatous colorectal polyps is done as a preventative measure against colorectal cancer; however, polyps can be overlooked, and when detected, polypectomy is not always 100% effective in eradicating a polyp. Our study suggests that daily intake of 3.0 g of bLF could be a clinically beneficial adjunct to colorectal polyp extraction.

Key Words: Lactoferrin • intestinal polyp • cancer prevention • clinical trial